生物仿制药市场研究

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进行彻底的生物仿制药市场研究有助于公司了解市场动态、监管变化和消费者偏好，确保他们能够做出推动增长和创新的战略决策。

The truth about biosimilars? They’re not just cheaper alternatives—they’re healthcare game-changers that most executives still don’t fully understand. I’ve sat across from pharmaceutical CEOs who dismissed them, only to watch their market share erode months later.

Having led SIS International through decades of market evolution, I can assure you that few sectors offer the complexity and opportunity that biosimilars present today. Our specialists have uncovered patterns that separate market leaders from those struggling to adapt—and the differences might surprise you.

企业为何需要生物仿制药市场研究？

Biosimilar market research is crucial for developing effective market entry and growth strategies. It identifies the market size, growth potential, and key drivers of demand. Companies can tailor their products and marketing strategies to meet the specific needs of different market segments by analyzing trends in patient adoption, healthcare provider preferences, and regional market variations.

而且， the biosimilar market is heavily regulated, with stringent requirements for approval and ongoing compliance. Therefore, biosimilar market research enables businesses to stay updated on regulatory changes, understand the approval processes in different regions, and anticipate potential regulatory hurdles. This knowledge helps companies develop regulatory strategies that ensure timely approval and compliance, reducing the risk of delays and additional costs.

此外， market research provides detailed competitive analysis, helping businesses understand their competitors’ strategies, strengths, and weaknesses. It is essential to identify market gaps, develop unique value propositions, and effectively position biosimilar products to gain a competitive advantage.

The Evolving Landscape of Biosimilars

The truth about biosimilars? They’re not just cheaper alternatives—they’re healthcare game-changers that most executives still don’t fully understand.

Market disruption is the daily reality reshaping pharmaceutical economics worldwide. The biosimilar market research we’ve conducted over the past five years reveals a startling truth: manufacturers who initially scoffed at biosimilar competition now scramble to develop their portfolios. You’re witnessing a fundamental shift in how biological therapies reach patients, with ripple effects touching everything from pricing strategies to R&D priorities.

… And what’s driving this transformation? It’s not just cost savings, though they’re substantial. Our latest biosimilar market research indicates that successful market entrants are those who understand the complex interplay between regulatory pathways, physician acceptance, and patient education. The barriers to entry remain high—developing a biosimilar isn’t like producing a simple generic pill—but the rewards for getting it right have never been greater.

The most successful organizations we’ve worked with approach biosimilar market research as an ongoing commitment rather than a one-time investment. They’re constantly testing assumptions, tracking evolving prescriber behaviors, and adjusting their commercialization strategies based on real-world evidence.

我们当前的市场回顾和建议

在 SIS International，我们认为生物仿制药市场正在经历显著增长，这得益于对具有成本效益的生物治疗的需求不断增长、主要生物制剂的专利到期以及有利的监管环境。我们的研究表明，随着越来越多的生物仿制药产品进入各个治疗领域，市场预计将继续扩大。

Additionally, healthcare providers’ and patients’ acceptance and adoption of biosimilars are on the rise, supported by increased education and awareness efforts. However, challenges such as regulatory complexities, competitive pressures, and the need for robust pharmacovigilance remain.

对企业的建议

1. 利用市场机会： 我们建议企业通过扩大产品组合和进入新的治疗领域来利用对生物仿制药日益增长的需求。通过识别高潜力市场和未满足的需求，企业可以开发针对特定患者群体的生物仿制药产品并获得竞争优势。
2. 加强监管策略： 了解监管环境对于成功推出和商业化生物仿制药至关重要。我们认为，企业应投资制定强有力的监管策略，以确保符合地区要求并促进及时审批。 
3. 增强利益相关者的参与： 在医疗保健提供者、付款人和患者中建立信任和信心对于广泛采用生物仿制药至关重要。我们认为企业应专注于全面的教育和沟通策略，强调生物仿制药的安全性、有效性和成本效益。 

Regional Variations in Biosimilar Adoption

Geographic differences in biosimilar uptake tell a fascinating story about healthcare systems and cultural attitudes toward innovation.

在 欧洲, where biosimilar market research shows impressive adoption rates, centralized purchasing decisions and physician incentives have created a flourishing ecosystem. Meanwhile, the U.S. market presents a more fragmented picture, with biosimilar market research revealing pockets of rapid adoption alongside areas of persistent resistance.

I’ve walked hospital corridors in Germany, where biosimilar utilization exceeds 90% for certain molecules, and contrasted this with facilities in parts of the U.S. where that figure struggles to reach 20%. Our biosimilar market research teams have identified key inflection points that predict when and how quickly adoption accelerates in different regions. It’s not simply about price—though that matters enormously—but about confidence in the regulatory framework and educational outreach.

Asian markets present perhaps the most dynamic picture of all. Our biosimilar market research in South Korea, India, and China reveals aggressive government policies promoting domestic development alongside unique physician education needs. We’ve helped multinational clients navigate these complexities, identifying partnership opportunities that leverage local knowledge while maintaining global quality standards.

生物仿制药市场研究的领先企业

在生物仿制药市场，几家领先的公司正在推动生物仿制药产品的创新、开发和商业化。这些公司利用全面的市场研究来了解监管环境、了解市场动态并定位自己的竞争力。以下是生物仿制药市场研究的一些领先公司：

安进

• 安进是全球生物技术领域的领导者，也是开发生物仿制药的先驱之一。安进非常重视研发，利用广泛的市场研究来发现机会并优化其产品线。 

山德士（诺华旗下的一个部门）

• 诺华旗下的 Sandoz 是生物仿制药市场的领先企业，拥有广泛的生物仿制药产品组合。该公司利用深入的市场研究来了解医疗保健提供商的偏好、监管要求和竞争格局。 

比奥康

• Biocon 是一家新兴的生物仿制药市场领导者，以其创新方法和全球影响力而闻名。该公司利用市场研究扩大其在关键市场的影响力并增强其竞争地位。 

辉瑞

• 辉瑞是生物仿制药市场的主要参与者，非常重视研发。该公司使用全面的市场研究来指导其生物仿制药战略，从产品开发到商业化。 

赛尔群

• Celltrion 是一家专门从事生物仿制药开发和生产的生物技术公司。该公司进行了广泛的市场研究，以确定市场需求、监管挑战和竞争机会。 

三星 Bioepis

• Samsung Bioepis 是 Samsung Biologics 和 Biogen 的合资企业，致力于开发高质量的生物仿制药。该公司利用市场研究来应对复杂的监管环境并了解市场动态。 

梯瓦制药

• Teva Pharmaceuticals 是仿制药和特种药物（包括生物仿制药）领域的全球领导者。该公司利用市场研究来指导其生物仿制药的开发和商业化战略。Teva 专注于患者可及性和成本控制，这推动了其努力将高质量的生物仿制药推向市场，为全球患者提供更实惠的治疗选择。

默克公司（MSD）

• 默克公司（在美国和加拿大以外称为 MSD）是生物仿制药市场的主要参与者。该公司进行了广泛的市场研究，以了解医疗保健提供者的偏好、监管挑战和市场机会。默克对创新和质量的承诺确保其生物仿制药产品符合最高的安全性和有效性标准。

Future Trends in Biosimilar Development

The next wave of biosimilars will transform therapeutic areas that have remained relatively untouched by this revolution. Our biosimilar market research forecasts indicate that ophthalmology, dermatology, and neurology will experience the kind of competitive reshaping that oncology and immunology have already undergone. You’re looking at a market that will nearly triple in value over the next decade, with particularly aggressive growth in emerging economies.

What makes this next phase different?

Biosimilar market research points to several key factors. Manufacturing technologies have advanced dramatically, lowering development costs. Regulatory pathways have become more predictable in major markets. And perhaps most importantly, the first generation of biosimilars has built credibility among clinicians who were initially skeptical but now have years of real-world experience with these products.

“The pioneers in biosimilar development faced headwinds that the next generation of products won’t encounter to the same degree—but they’ll face new challenges that require equally sophisticated market intelligence,” as one of our senior analysts recently noted in our global biosimilar market research report.

I’ve advised clients to pay particular attention to how digital health technologies reshape patient monitoring capabilities. Our biosimilar market research indicates that biosimilar manufacturers who can offer compelling value-added services—not just competitive pricing—will increasingly differentiate themselves in crowded therapeutic categories. We’re already seeing this play out in diabetes and growth hormone therapies, where device integration and patient support programs have become competitive battlegrounds.

Competitive Analysis in the Biosimilar Space

When we conduct biosimilar market research focused on competitive positioning, we often uncover development programs that aren’t widely publicized but could fundamentally alter market entry timing decisions. You’re operating in an environment where being third-to-market with the right strategy often outperforms being first with the wrong one.

Our biosimilar market research methodology combines traditional pharmaceutical intelligence gathering with specialized approaches developed specifically for this unique market. We track not just which molecules are in development, but also manufacturing capacity investments, clinical trial site selections, and patent litigation strategies that signal competitors’ intentions and capabilities.

What distinguishes high-value biosimilar market research is the ability to forecast product approvals and adoption curves across different customer segments. We’ve developed sophisticated models incorporating stakeholder research, analog analysis, and payer dynamics to help clients realistic volume projections at launch and throughout the product lifecycle as competitive intensity increases.

Biosimilar Market Research – Key Insights

- Market Disruption: Biosimilars are fundamentally reshaping pharmaceutical economics, with even skeptical manufacturers now developing their biosimilar portfolios.

- Success Factors: Leading companies in the biosimilar space excel through deep stakeholder insights rather than just competitive pricing, understanding the interplay between regulatory pathways, physician acceptance, and patient education.

- Regional Variations: Significant differences exist in adoption rates across regions, with Europe showing adoption rates up to 90% for certain molecules while some U.S. regions struggle to reach 20%.

- Asian Markets: Countries like South Korea, India, and China present unique opportunities with aggressive government policies promoting domestic development alongside specific education needs.

- Stakeholder Complexity: Successful biosimilar launches require orchestrating messages across multiple audiences simultaneously, including payers, hospital administrators, patient groups, and regulatory authorities.

- Value Thresholds: Different stakeholders require different cost savings to find biosimilar value propositions compelling—hospital pharmacists may demand 30% savings. In comparison, integrated health systems might change formularies at just 15% if supply reliability is high.

- Emerging Therapeutic Areas: The next wave of biosimilars will transform ophthalmology, dermatology, and neurology, with market value expected to nearly triple over the next decade.

- Regulatory Navigation: Significant differences in approval requirements across regions necessitate sophisticated intelligence to design efficient development programs meeting diverse expectations.

- Competitive Positioning: Being third-to-market with the right strategy often outperforms being first with the wrong approach—successful companies track molecules in development, manufacturing investments, and patent litigation strategies.

- 数字化集成: Forward-thinking biosimilar manufacturers differentiate themselves through value-added services like device integration and patient support programs, particularly in diabetes and growth hormone therapies.

SIS International 的生物仿制药市场研究如何帮助企业

我们在生物仿制药市场研究方面的专业知识涵盖了市场动态、监管环境和竞争分析的各个方面，使企业能够做出明智的决策并实现其战略目标。以下是我们在生物仿制药市场中的市场研究如何帮助企业：

增加收入

Our research helps companies understand which products or services resonate most with healthcare providers and patients, enabling them to focus on high-potential areas. 

降低风险

我们为企业提供洞察，帮助他们识别潜在风险并制定缓解策略。我们的研究可帮助企业做出明智的决策，从而降低出现代价高昂的错误的可能性，并确保在面临挑战时具有韧性。

提高营销效率

SIS 国际 market research services help businesses identify the most effective marketing channels, messages, and strategies to reach their target audience. 

加速增长和创新

Our research services provide businesses with the insights to identify emerging trends and consumer needs, fueling innovation and growth. 

长期合作伙伴关系

We believe in building long-term partnerships with our clients. SIS International provides ongoing support and consultation to help businesses adapt to market changes and continuously refine their strategies. Our commitment to client success ensures you have a trusted partner to rely on as you navigate the biosimilar market. 

 

常见问题解答

1. What makes biosimilar market research different from traditional pharmaceutical research?

Biosimilar market research requires a more comprehensive stakeholder approach than traditional pharmaceutical research. While traditional research often focuses heavily on prescriber preferences, biosimilar research must include payers, hospital administrators, patient advocacy groups, and regulatory authorities—all of whom significantly influence adoption. Additionally, biosimilar research must account for unique considerations like interchangeability, switching studies, and reference product selection that don’t exist in other pharmaceutical categories.

2. How long do biosimilars typically take to gain significant market share after launch?

Market share acquisition varies dramatically by region, therapeutic area, and molecule. In Europe, where centralized purchasing decisions and physician incentives support adoption, biosimilars can capture 50-80% market share within 12-24 months for well-established molecules. In the U.S., adoption has historically been slower, though this is changing with improved stakeholder education and evolving payer policies. Our research shows that oncology biosimilars typically gain traction faster than those in immunology, and hospital-administered products generally see quicker uptake than self-administered ones.

3. What are the most common barriers to biosimilar market entry for entrepreneurs?

The primary barriers include:
1) High development costs and technical complexity, requiring sophisticated manufacturing capabilities;
2) Patent thickets created by reference product manufacturers;
3) Regulatory uncertainty in some regions;
4) Physician and patient education needs; 5) Reference product manufacturer defensive strategies including contracting tactics and product improvements;
6) Limited differentiation opportunities beyond price; and
7) Challenges in building credibility with key stakeholders as a new entrant. Successful entrepreneurs typically address these through strategic partnerships, focused therapeutic area selection, and innovative go-to-market approaches.

4. How important is interchangeability designation for biosimilar commercial success?

While interchangeability designation can be valuable in certain market segments, particularly retail pharmacy-dispensed products, our research shows it’s not universally necessary for commercial success. Building prescriber confidence through strong clinical data and education often proves more important than interchangeability designation in hospital and clinic settings where physicians actively prescribe products. The significance of interchangeability varies substantially by therapeutic area, product administration setting, and regional pharmacy substitution laws.

5. What role do value-added services play in biosimilar competition?

As more biosimilars enter the same therapeutic spaces, value-added services are becoming increasingly important differentiators. Our research indicates that services like patient support programs, simplified reimbursement assistance, injection training, and digital monitoring tools can significantly influence adoption decisions when multiple biosimilars offer similar pricing. For entrepreneurs entering the space, strategically designed service offerings that address specific stakeholder pain points can create competitive advantage without requiring the massive investments to compete solely on price.

6. How are biosimilar pricing strategies evolving as markets mature?

Early biosimilar entrants typically launched with modest discounts (15-30%) to reference products, but pricing strategies have become more sophisticated as competition intensifies. In mature biosimilar markets like Europe, we now see average discounts of 30-70% depending on the therapeutic area and competitive intensity. Contract structures have also evolved beyond simple percentage discounts to include volume-based tiering, outcomes guarantees, and portfolio-based contracting. Entrepreneurs should be prepared for aggressive pricing competition in established biosimilar categories while potentially finding more pricing flexibility in newly-opening therapeutic areas.

7. What capabilities are most critical for new entrants to develop when entering the biosimilar space?

Beyond the obvious technical and regulatory capabilities required for development, successful new entrants must excel at:

1) Stakeholder mapping and engagement across the entire ecosystem;
2) Health economic modeling that quantifies value beyond simple acquisition cost;
3) Educational content development tailored to different stakeholder concerns;
4) Supply chain reliability and scalability;
5) Competitive intelligence gathering;
6) Nimble commercial operations that can adapt to rapidly changing market conditions; and
7) Strategic partnership development to complement internal capabilities. Our research consistently shows that companies underinvesting in these areas struggle even with technically excellent products.

我们的纽约工厂地址

纽约州纽约市东22街11号2楼 10010 电话：+1(212) 505-6805

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关于 SIS 国际

SIS 国际 提供定量、定性和战略研究。我们提供决策所需的数据、工具、战略、报告和见解。我们还进行访谈、调查、焦点小组和其他市场研究方法和途径。 联系我们 为您的下一个市场研究项目提供帮助。